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Manufacturing Specialist I/II, Manufacturing Technical Operations (MTO)

Biogen

Manufacturing Specialist I/II, Manufacturing Technical Operations (MTO)

National
Full Time
Paid
  • Responsibilities

    Job Description

    In this Manufacturing Specialist role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be highly detail oriented with excellent technical writing skills and a continuous improvement mindset.

    WHAT YOU’LL DO:

    • Author manufacturing documentation including Master Production Records, Solution Lot Records, procedures, and work instructions and deliver on key stakeholder requirements with a minor degree of supervision.
    •  Support the technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met.
    • Initiate, own, and manage manufacturing focused change controls, CAPAs, and planned exceptions
    • Project management and project execution – lead or participate in projects (moderate to complex in nature), facilitating timely execution.
    • Partner with cross functional groups (e.g. Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation
    • This site-based role supports MFG, primarily during core weekday business hours, but may require infrequent off-hours support.

    WHO YOU ARE:

    If you are a highly detailed and focused individual who demonstrates a moderate to advanced level of technical process knowledge, technical writing ability, and subject matter expertise with manufacturing processes and equipment, you would be a great fit for our Manufacturing Technical Operations Team!  This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives. 

  • Qualifications

    Qualifications

    MANUFACTURING SPECIALIST I

    2+ years relevant experience in addition to a Bachelor’s degree of Life Sciences or Engineering preferred. Other educational levels accepted based on related experience

    MANUFACTURING SPECIALIST III

    4+ years relevant experience in addition to a Bachelor’s degree of Life Sciences or Engineering preferred. Other educational levels accepted based on related experience

    PREFERRED SKILLS:

    • Prior experience in manufacturing – Drug substance Cell Culture, Purification, or Harvest/Cell Clarification.
    • Understanding of business processes and roles of cross-functional groups supporting manufacturing operations.
    • Robust understanding of quality and cGMP principles.
    • Fundamental knowledge of change control in cGMP environment.
    • Intermediate to advanced skills in Microsoft Office and computer-based quality systems.
    • Intermediate to advanced level of technical writing skill.
    • Ability to interpret manufacturing process design documentation.

    Additional Information

    Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

    All your information will be kept confidential according to EEO guidelines.

  • Industry
    Manufacturing